At a Glance
- Tasks: Lead regulatory activities for EMEA medicinal products and ensure compliance with EU regulations.
- Company: Dynamic healthcare company focused on innovation and collaboration.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Join a multicultural team and thrive in a fast-paced environment.
- Why this job: Make a real impact in the healthcare sector while navigating exciting regulatory challenges.
- Qualifications: Bachelor's degree and 6+ years of regulatory experience in EU procedures.
The predicted salary is between 63000 - 77000 £ per year.
- Sonning, Burghfield, Lower Earley, Binfield Heath
- Full Time
What you will do
The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with
EMEA medicinal products .
Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).
What You Will Do
- Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.
- Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates.
- Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Prioritizes, plans and monitors allocated projects against defined timelines
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
- Ensures that all assigned products comply with local regulatory and quality system requirements.
- Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained
- Identifies & initiates local process improvement opportunities and manage changes as required
- Assists in the preparation for internal and external audits and inspections in collaboration with others
- Partner with other critical functions to execute plans to address crises and other sensitive issues
Qualifications
- Required Qualifications
- Relevant Bachelor's Degree or higher
- 6+yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
- Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates.
- Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
- Good interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
- Strong organizational and time management skills with an ability to work under pressure.
- Able to work effectively in a multi-cultural, highly matrixed organization
- Proficiency in English
- Desired Qualifications
- Knowledge of consumer healthcare environment and product development
- Understanding of processes and departments within a healthcare company
- Effective time and organisation management
- #J-18808-Ljbffr
Senior Regulatory Affairs Specialist in Reading employer: High5
High5 is an exceptional employer that values the contributions of its Clinical Research Associates by fostering a collaborative and supportive work culture. With a strong emphasis on professional development, employees are encouraged to grow their skills through ongoing training and mentorship opportunities, all while enjoying the flexibility of travel across the UK for site monitoring. Join us to be part of a team dedicated to advancing oncology research in a meaningful and impactful way.
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We think this is how you could land Senior Regulatory Affairs Specialist in Reading
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We think you need these skills to ace Senior Regulatory Affairs Specialist in Reading
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at High5!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show High5 that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at High5!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At High5, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at High5
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at High5 that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with High5’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
